The illicit use of prescription drugs has become a major healthcare problem. In the US in 2002, six million individuals were estimated to have used prescription drugs for non-medical purposes. Eleven percent of all US prescriptions are for the most high-risk form of medications, known as Controlled Substances. The cost to the healthcare system of prescription drug abuse and diversion was estimated to be $100 billion in the US in 2001.
Drugs are obtained illicitly through a variety of means including drug theft, illegal Internet shopping, prescription forgery, illegal prescriptions from physicians and doctor shopping. The most common drugs diverted include opiates (particularly hydrocodone, oxycodone, fentanyl and methadone), tranquilizers (diazepam and alprazolam), stimulants such as methylphenidate and sedatives. The diversion of pain medications is one of the most severe healthcare problems, with the addictive nature of the drugs causing enormous challenges to users and their families. The incentive for fraud and diversion is very significant. For example, a Medicaid patient can obtain 100 80-mg pills of OxyContin for $30 with a street re-sale price of $8,000.
The magnitude of the diversion of medications for pain, anxiety, and learning disorders, often from the highly-scrutinized Controlled Substances category, has resulted in the disruption of normal doctor-patient trust and interactions. In accord with The Federation of State Medical Boards guidance, a doctor will routinely require a new patient to sign a contract prior to providing a Controlled Substance prescription. The terms of the contract will often include a stipulation for the patient to be subjected to random blood or urine drug testing in order to monitor the individuals' compliance with the medication regimen.
A drug testing industry has developed to support this management approach. The extent of the diversion problem is highlighted from data generated in such programs. In one study, drug monitoring indicated that more than 70% of patients were out of compliance with their regimen and 39% had the prescribed drug or metabolites completely absent. Because internet-savvy drug users and organized criminals understand the pharmacokinetic basis of the testing, the tests can be used to feign compliance and hence further manipulate the prescriber.
Considerable resources and expenditures have been invested in attempts to reduce the diversion problem. Drug developers have attempted to make pain medications more challenging to illicit users by the development of sustained release forms, pro-drugs, and alternative modes of administration such as dermal patches instead of pills. However, the resourcefulness of illicit drug users and supplier organizations has generally overcome these impediments.
The use of electronic monitoring systems to combat the problem generally has been limited to methods to track prescription patterns in order to flag unusual prescription volume by a doctor or multiple prescriptions sought by an individual from multiple doctors. However, these solutions are circumvented by organized criminals and, hence, only address a portion of the problem. Previously, there have not been any solutions that enable the robust tracking of drugs after they have been provided to the prescribed end-user, nor have there been systems and methods that enable authorities to differentiate between normal patient behaviors and criminal activities.
Accordingly, there is a need for a system and method to enable the tracking of dosage forms after they have been provided to the legal end-user and enable a robust assessment of patient compliance with prescribed drug regimens.